Software Development for Medical Devices

Software Development for Medical Devices

Accelerate innovation with our medical device software solutions, covering full-cycle
medical device software development services, from design to post-market support.

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Software services for medical devices by Yalantis

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Software for medical devices

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Software as a medical device (SAMD)

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Healthcare IT consulting and compliance

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Quality assurance (QA)

Software for medical devices

  • Development and maintenance of custom medical device software
  • Data retention and interoperability
  • Supplementary infrastructure for medical devices (software gateways, APIs)
Software for medical devices

Software as a medical device (SAMD)

  • Telehealth platforms with remote patient monitoring
  • Treatment software
  • Custom medical imaging software
  • Analytics for processing medical device data
Software as a medical device

Healthcare IT consulting and compliance

  • Market analysis to determine the right medical device
  • Consulting on cybersecurity measures
  • Regulatory compliance consulting – HIPAA, GDPR, ISO 13485, ISO/IEC 80001
  • Guidance on UI/UX design and business intelligence
Healthcare IT consulting and compliance

Quality assurance (QA)

  • Medical device calibration and configuration
  • Precise data collection
  • Supporting high software quality
  • Dedicated QA team for testing medical devices and software
Quality assurance (QA)
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Software for medical devices

  • Development and maintenance of custom medical device software
  • Data retention and interoperability
  • Supplementary infrastructure for medical devices (software gateways, APIs)
Software for medical devices
icon

Software as a medical device (SAMD)

  • Telehealth platforms with remote patient monitoring
  • Treatment software
  • Custom medical imaging software
  • Analytics for processing medical device data
Software as a medical device
icon

Healthcare IT consulting and compliance

  • Market analysis to determine the right medical device
  • Consulting on cybersecurity measures
  • Regulatory compliance consulting – HIPAA, GDPR, ISO 13485, ISO/IEC 80001
  • Guidance on UI/UX design and business intelligence
Healthcare IT consulting and compliance
icon

Quality assurance (QA)

  • Medical device calibration and configuration
  • Precise data collection
  • Supporting high software quality
  • Dedicated QA team for testing medical devices and software
Quality assurance (QA)
  • icon

    Software for medical devices

    • Development and maintenance of custom medical device software
    • Data retention and interoperability
    • Supplementary infrastructure for medical devices (software gateways, APIs)
    Software for medical devices
  • icon

    Software as a medical device (SAMD)

    • Telehealth platforms with remote patient monitoring
    • Treatment software
    • Custom medical imaging software
    • Analytics for processing medical device data
    Software as a medical device
  • icon

    Healthcare IT consulting and compliance

    • Market analysis to determine the right medical device
    • Consulting on cybersecurity measures
    • Regulatory compliance consulting – HIPAA, GDPR, ISO 13485, ISO/IEC 80001
    • Guidance on UI/UX design and business intelligence
    Healthcare IT consulting and compliance
  • icon

    Quality assurance (QA)

    • Medical device calibration and configuration
    • Precise data collection
    • Supporting high software quality
    • Dedicated QA team for testing medical devices and software
    Quality assurance (QA)

Benefits of Yalantis as a medical device software development company

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Full-Cycle Development Expertise

From device firmware to cloud platforms, we deliver end-to-end software development medical devices to meet the requirements of your medical project.

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Regulatory-Ready Solutions

We design software for medical devices that aligns with FDA, MDR, and ISO 13485 to ensure faster compliance and safer deployments.

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Intelligent Diagnostics Automation

Automate diagnostics and lower manual effort with custom medical device software solutions that simplify workflows and improve accuracy.

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Human-Centered Patient Experience

Build digital ecosystems that reduce patient stress and improve care outcomes using intuitive, functional software for medical devices.

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Full-Cycle Development Expertise

From device firmware to cloud platforms, we deliver end-to-end software development medical devices to meet the requirements of your medical project.

Benefits icon

Regulatory-Ready Solutions

We design software for medical devices that aligns with FDA, MDR, and ISO 13485 to ensure faster compliance and safer deployments.

Benefits icon

Intelligent Diagnostics Automation

Automate diagnostics and lower manual effort with custom medical device software solutions that simplify workflows and improve accuracy.

Benefits icon

Human-Centered Patient Experience

Build digital ecosystems that reduce patient stress and improve care outcomes using intuitive, functional software for medical devices.

Testimonials from our clients

The thing that has been unique in my experience working with Yalantis is that they aren’t a factory that you send over some requirements and they develop exactly to those requirements—whether good, bad, or indifferent—and then ship you back some products. It’s a much more interactive process, and the team at Yalantis, from the business analysts to developers, are very good at saying: “There might be a better way of doing this—why don’t you take a look at this?” They bring a really intelligent and dynamic approach to the engagement that you don’t get sometimes with other vendors.

Simon Jones

CIO in Healthcare

“What fascinated me the most is how invested the Yalantis development team is, and how they often exceeded expectations in what we were trying to accomplish in terms of timeframes.”

Sérgio Miguel Vieira

Founder and CEO

“They have very good organization and project management expertise. We’re not just getting the developers, we’re getting a whole support structure. Also, Yalantis cares about their employee satisfaction. And with satisfied employees, we get much better output.”

Sergei Lishchenko

Director of Digital Experience

“What triggered us was their remote collaboration practices as well as their experience in the IoT industry. Their strong technical experience helped us scale our platform and deliver great performance to our customers.”

Roy

Partner at RAKwireless

“One of the biggest values they bring to the table is the way of thinking critically during the whole development process. They’re not just building software, they’re effectively solving your business problem.”

Ron Bullis

President and Founder at Lifeworks Advisors

“Yalantis has been a great fit for us because of their experience, responsiveness, value, and time to market. From the very start, they’ve been able to staff an effective development team in no time and perform as expected.”

Mark Boudreau

Founder and COO at Healthfully

“Established development flows and good communication skills made collaboration with Yalantis very smooth. We appreciate their professionalism and dedication. If you are looking for a solid technical partner and a well-processed software outsourcing company for your project, I’d recommend Yalantis.”

Ken Yu

CEO at RAKwireless

“Working with Yalantis, you get their breadth of experience building hundreds of projects. Their expertise and knowledge were second to none. And that makes the difference between a good product and a great product.”

Andrew Gazdecki

CEO at MicroAcquire

“With the product built by Yalantis, we have a lot of possibilities for growth. They elaborated a great user experience for our operators to work more efficiently and properly deal with troubleshooting. And the architecture of the product is scalable and ready for the future.”

Alejandro Resendiz

General manager at 123 Sourcing

“Working with Yalantis is really good and we’re satisfied with the partnership so far. They helped us with whole aspects of development, like front-end, back-end, DevOps, and product management. They are very good when it comes to communication and organizing. They meet our deadlines all the time, plan everything carefully. Also, the team writes high-level code. Overall, I’m very impressed with Yalantis communication and how they manage everything. Their quality is very high.”

Gonen Krak

CTO & Co-founder of AironWorks

Yalantis played a crucial role in accelerating our SDK development. They ensured seamless integration with our existing back-end, keeping product quality high and delivering on schedule. One of the biggest advantages of workers in Yalantis is that they’ve become the knowledge keepers of our SDK, ensuring continuity, scalability, and smooth onboarding for the new members. I would definitely recommend Yalantis to any company looking for a trusted development partner.

Oleg Lesov

CEO at Reteno

FAQ

How do you handle integration issues with existing healthcare systems?

Challenges in medical device software development often originate from poor vendor documentation or integrating multiple devices. We handle this by working with vendors directly or suggesting better-documented alternatives. For multi-device setups, we merge and normalize data to ensure smooth processing. Every project is unique, so issues may vary.

Can you assist with FDA or MDR compliance for medical device software?

Yes. We ensure your software design for medical devices aligns with FDA, MDR, and ISO 13485 requirements, supporting faster approvals and safe releases.

Do you develop Software as a Medical Device (SaMD)?

That’s what we do! We offer medical device software engineering for SaMD products, from risk analysis and UI design to cloud connectivity and compliance.

Can you integrate medical devices with EHR or hospital systems?

We can. Yalantis provides software services for medical devices that support integration with EHRs, hospital platforms, and HL7/FHIR standards.

How do you ensure the interoperability of connected medical devices?

We develop medical device software solutions that standardize and synchronize data across various devices, so the data exchange is smooth and compliant.

Do you provide validation and verification services for medical software?

Yes, we do it as part of our medical device software development services. We conduct strict V&V testing to ensure software safety, reliability, and compliance.

What is your experience with healthcare and medtech interoperability?

We’ve integrated healthcare systems with all classes of FDA-approved devices and built custom solutions from scratch. The experts from Yalantis develop medical device software for diagnostics, remote monitoring, and chronic disease management to ensure seamless data integration and faster, more accurate care delivery.

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    Nick Orlov photo

    Nick Orlov

    Engagement Manager

    How to get started with IoT development

    • Get on a call with our Internet of Things product design experts.

    • Tell us about your current challenges and ideas.

    • We’ll prepare a detailed estimate and a business offer.

    • If everything works for you, we start achieving your goals!